Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Diabetic Neuropathy

February 9, 2017 updated by: Imam Abdulrahman Bin Faisal University

Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients

This study are to:

  • Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients.
  • Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients.
  • Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy in diabetic patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sixty- five male and female diabetic patients with peripheral neuropathy will be selected to participate in this study. They will be equally divided into two groups Group-I: Twenty five patient with diabetic peripheral neuropathy will be exposed to low intensity pulsed magnetic therapy Group-II: Twenty five patients with diabetic peripheral neuropathy will be exposed for 24 treatment sessions of laser therapy Group-III 15 patient received only medical treatment

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All diabetic patients with peripheral neuropathy will be selected to participate in this study.
  • Their age ranges from 35 to 65 years old.
  • All patients under medical control (optimal blood glucose). such as analgesic medications (e.g. opiates, anti-depressants, anticonvulsants and diabetic drugs to control blood glucose).

Exclusion Criteria:

  • Patients have DPN due to other causes than diabetes
  • Ulcers in either foot
  • Lack of blood sugar control
  • Other nervous system impairments
  • Visual problems
  • Unstable medical conditions
  • Pregnancy
  • Metallic implants
  • Alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Magnetic Therapy
Twenty five patient were exposed to low intensity pulsed magnetic therapy with a frequency of 200 Hertz and intensity of 50 Gauss for 30 minutes / session for 2 times per week for 3 months .
Device: Magnetic therapy
low intensity pulsed magnetic therapy with a frequency of 200 Hertz and intensity of 50 Gauss . Magnetic device will be applied on each patient from a comfortable supine lying position. After the connection of appliance to electrical supply, the actions of PEMF will be directed and adjusted over lumbar spine, hip regions and calf muscles of both lower limbs.
Experimental: Laser Therapy
Twenty five patients were treated with 24 sessions of laser therapy at a rate of two sessions / week for three months. Each patient will be exposed to Helium neon infrared laser (850 nano-meter continuous wave mode from a comfortable prone lying position.
Device: laser therapy
laser therapy of Helium neon infrared laser (850 nano-meter) was used in continuous wave mode from a comfortable prone lying position on the whole plantar surface of the foot and the lumbo-sacral area by four points, and two points laterally to the spine.
Experimental: Medical therapy
Fifteen patients were received only medical treatment .
Drug: Only medical treatment
Fifteen patients with diabetic peripheral neuropathy were treated with antidiabtic drugs and lyrica 150 milligram daily
Other Names:
  • Lyrica 150 milligram

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Motor and sensory conduction velocity of the lower limb nerves
Time Frame: 30-45 minutes
it is used for measuring motor and sensory conduction velocity: For this purpose nerve conduction studies (NCSs) will be performed for all patients including evaluation of bilateral peroneal and tibia motor nerves and sural sensory nerves (Asad 2009). Patients with NCV from 33-48m /sec will be recruited in this study (Pericz and Cvetkovic 2006 , and Graak 2009). All measurement will be done at stander room temperature of 25 c. The skin temperature of the leg was maintained at 37ᴄ. (Asad et al 2009).
30-45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imam Abdulrahman Bin Faisal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Enas F. Alananey, PhD, Associate professor university of Dammam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individuals date not shared but the final results comments will appear only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings